200 Participants NeededMy employer runs this trial

LINQ® Procedure for Sacroiliitis

(LINQT Trial)

LV
Overseen ByLalit Venkatesan, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and effectiveness of the LINQ fusion procedure for treating sacroiliac joint (SIJ) dysfunction, which causes pain in the lower back and buttock area. Researchers will divide participants into two groups: one will undergo the LINQ procedure, while the other will follow standard non-surgical treatments. The trial seeks individuals who have experienced significant lower back or buttock pain for at least six months and have been diagnosed with SIJ dysfunction. As a Phase 4 trial, the LINQ procedure is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

What is the safety track record for the LINQ fusion procedure?

Research has shown that the LINQ fusion procedure is generally safe for treating sacroiliac joint (SIJ) problems. In one study, no patients experienced negative side effects or complications after the procedure. Another review noted that while rare issues like implant misplacement can occur, further surgery is usually only necessary if significant new pain arises. Overall, studies report positive outcomes, including pain relief and improved movement. Patients express greater satisfaction with the LINQ procedure compared to non-surgical treatments, indicating that most handle it well.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the LINQ fusion procedure for sacroiliitis because it offers a minimally invasive alternative to traditional treatments like physical therapy, medication, and more extensive surgeries. Unlike conventional methods that often require long recovery times or ongoing management of symptoms, the LINQ procedure aims to directly stabilize the sacroiliac joint using a small implant. This approach could potentially reduce pain more effectively and shorten recovery periods, making it a promising option for patients suffering from SIJ pain.

What evidence suggests that the LINQ fusion procedure is effective for sacroiliitis?

Research has shown that the LINQ fusion procedure effectively treats sacroiliac joint (SIJ) problems. This minimally invasive procedure involves less cutting and shorter recovery time. In this trial, participants in the Treatment Arm will undergo the LINQ Procedure. Studies have found that it significantly reduces pain and improves mobility over time. Specifically, one study reported a substantial pain reduction, with an average improvement of 55.4 points after two years. Another study found that it stabilized the joint by reducing unwanted movement. Overall, the LINQ procedure significantly improves the quality of life for most people with SIJ issues.56789

Are You a Good Fit for This Trial?

This trial is for adults aged 21 or older with a BMI of 40 or less who have had lower back or buttock pain from sacroiliac joint (SIJ) dysfunction for at least 6 months, haven't improved with non-surgical treatments, and meet specific tests confirming SIJ problems.

Inclusion Criteria

My age and BMI meet the study requirements.
I am 21 years old or older.
2. BMI ≤ 40.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Randomization and Baseline Procedure

Participants are randomized to either the LINQ Procedure or Conventional Medical Management (CMM) and undergo the baseline procedure or initiation of CMM

1 week
1 visit (in-person)

Treatment

Participants receive either the LINQ Procedure or continue with CMM. Follow-up visits occur through 24 months

24 months
Visits at Months 1, 3, 6, 12, 18, 24 (in-person)

Crossover (optional)

Participants in the Control Group may opt to crossover to receive the LINQ procedure after the 6 Month evaluation

18 months post-crossover
Follow-up visits through 18 months post-crossover

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Visits at Months 1, 3, 6 (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • LINQ fusion procedure

Trial Overview

The study compares the LINQ fusion procedure—a minimally invasive surgery using bone grafts—to standard non-surgical care (like physical therapy and medications) to see which works better for treating sacroiliac joint pain.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Conventional Medical Management (CMM)Active Control1 Intervention
Group II: Treatment Arm (LINQ Procedure)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

PainTEQ, LLC

Lead Sponsor

Trials
1
Recruited
160+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40832586/

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